1. Technical Field
The present invention relates to a device for closing an opening formed in the wall of a body vessel while carrying out a medical procedure. More particularly, the invention relates to a vascular closure device for closing an opening during deployment of a medical interventional device into the vascular system.
2. Background Information
There are many medical procedures in which a tube, catheter, and/or wire is temporarily inserted into or out of a blood vessel. For example, the Seldinger technique is performed by inserting a hollow needle through a patient's skin and muscle tissue into the vascular system. It is preferable that the needle is passed through the entire vessel, and then pulled back at a steeper angle until blood from the blood vessel flashes in the needle but not all the way out. A guide wire is then passed through the lumen of the needle into the blood vessel. The needle is removed and an introducer sheath is advanced over the guide wire into the vessel. A catheter typically is passed through the lumen of the introducer sheath and advanced over the guide wire into position for a medical procedure, such as angiography, angioplasty, plaque removal, and infusion of a therapeutic agent. As a result, the introducer sheath can facilitate insertion of various devices into the vessel while minimizing trauma to the vessel wall and minimizing blood loss during a procedure. Upon completion of the medical procedure, the catheter and introducer sheath are removed, leaving a puncture vascular access site or opening.
The vascular access site is usually sutured or closed manually by providing pressure with a pressure bandage, compressive weight or clamp device until clotting and wound sealing occurs. The manual pressure method, however, can take half an hour or more and can require the patient to remain immobilized for at least that period of time and be kept in the hospital for observation. Rate of post-puncture hemorrhage can be high leading to considerable complications. There may also be a possibility for clots at puncture site to be dislodged.
Sutures may have procedure variability, but still require time to close the vessel. Sutures typically close the vascular access site by using a “purse-string” suture, in which a single thread is stitched to surround the access site and then pulled tight (like a purse-string) to close the access site. Performing this suture requires skill and practice to capture the suture, withdraw the suture, tie the knot, and cut the suture. It also may be difficult to perform the suturing in a key-hole procedure or in other types of surgery where there is limited access to the wound site. A nidus for thrombus or instravascular mural hyperplasia with later spontaneous and catastrophic closure of the vessel is known to occur because the suture remains intravascularly on the endothelial surface.
It would be desirable to provide an improved closure device, an introducer system, and methods of use therewith, for closing an opening formed in the wall of a body vessel while carrying out a medical procedure that do not suffer from the drawbacks of the conventional approaches.